An Open-label, Single-center, 4-week Phase I Trial Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of GRT6019 in Healthy Male Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of participants with Adverse Events (AEs)
研究概览
简要总结
The purpose of this trial is to assess the safety, tolerability, and PK of 3 doses of GRT6019 in healthy male participants.
This Phase I trial will be a multiple dose trial in healthy male participants with administration of GRT6019 in 3 cohorts.
For each participant, the trial consists of a Screening Period of up to 28 days, a 4 week Treatment Period (including a 2-week clinic stay and 2 weeks in an outpatient setting), and a 5 week Follow-up Period.
详细描述
There are 8 participants planned per cohort to ensure sufficient sample size for a reliable estimate of PK parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Main Inclusion Criteria:
- •Participant must be male, 18 to 55 years of age (inclusive) at the time of signing the informed consent form and affiliated to the social security system.
- •Participant must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •Participant must sign the informed consent form before any trial-related assessments.
- •The participant is in good health as determined by the medical history, physical examination, 12-lead ECG, vital signs (heart rate, respiratory rate, systolic and diastolic blood pressure [BP]), body temperature, and clinical laboratory parameters (clinical chemistry, hematology, coagulation, and urinalysis) without clinically relevant (per investigator judgement) deviations from reference ranges unless further specified in the
排除标准
- •. The population of this clinical trial is healthy volunteer participants.
- •Main Exclusion Criteria:
- •Any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, comparator, rescue medication, or any ingredients therein, or may affect the interpretation of the results, or may render the participant at high risk from treatment complications/ participation in the study unsafe
- •Major surgical procedure, within 3 months prior to ICF signing, or anticipation of need for a major surgical procedure during the trial
- •Clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, or immunological disorder(s)
- •Regularly uses any medication, including herbal remedies or over-the-counter medication within 2 weeks before screening into this trial and anticipated use during the trial
- •Concurrent enrollment in another clinical trial, unless it is an observational (non interventional) clinical trial or during the follow-up period of an interventional trial
- •Recent participation in another clinical trial with an IMP administered within 30 days before Day 1 or within 5 times the elimination half-life of the IMP, whichever is longer
研究组 & 干预措施
GRT6019: Cohort 1
4 weeks dosing with GRT6019 low dose once a day [QD]
干预措施: GRT6019 (Drug)
GRT6019: Cohort 2
4 weeks dosing with GRT6019 medium dose once a day [QD]
干预措施: GRT6019 (Drug)
GRT6019: Cohort 3
4 weeks dosing with GRT6019 higher dose once a day [QD]
干预措施: GRT6019 (Drug)
结局指标
主要结局
Number of participants with Adverse Events (AEs)
时间窗: Through study completion, an average of 4 Weeks
Assessment of safety and tolerability of GRT6019 following 4 weeks of treatment
Number of participants with Serious Adverse Events (SAEs)
时间窗: Through study completion, an average of 4 Weeks
Assessment of safety and tolerability of GRT6019 following 4 weeks of treatment
Number of participants with AEs leading to discontinuation
时间窗: Through study completion, an average of 4 Weeks
Assessment of safety and tolerability of GRT6019 following 4 weeks of treatment
Number of participants with AEs related to investigational medicinal product [IMP]
时间窗: Through study completion, an average of 4 Weeks
Assessment of safety and tolerability of GRT6019 following 4 weeks of treatment
次要结局
- Area under the concentration-time curve over the dosing interval (AUCtau)(Following the first dose (Day 1), then at Day 14, and after the last dose (Day 28))
- Maximum observed concentration (Cmax)(Following the first dose (Day 1), then at Day 14, and after the last dose (Day 28))